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Kula N. Jha

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FDA investigator. Took part in 6 inspections of 6 companies, 2023–2026.

Inspections (6)
DateCompanyClassificationProject areaInspection
September 2, 2026Organogenesis IncNot classified#1341218
April 30, 2025ULTRAGENYXNot classified#1269530
April 25, 2025Ultragenyx Pharmaceutical Inc.Not classified#1269681
April 30, 2024Autolus LimitedNot classified#1252993
November 20, 2023Novartis Pharma Stein AGNot classified#1230809
September 1, 2023Grifols Therapeutics LLCNot classified#1221101
Documents (6)
  • WARNING LETTER · Unetixs Vascular, Inc. · December 4, 2025
  • 483 · Ultragenyx Pharmaceutical Inc. · April 25, 2025
  • 483 · Ultragenyx Pharmaceutical Inc. · April 25, 2025
  • 483 · BioMarin Pharmaceutical, Inc.
  • 483 · Autolus Limited
  • 483 · ULTRAGENYX · April 30, 2025
Frequently inspected with (10)
Massoud Motamed

Biologist at CBER

3 shared
Jacob L. Bitterman
2 shared
Jessica Chery
2 shared
Kathleen R. Jones

investigator

2 shared
Timothy Kamaldinov
2 shared
Andrew E. Timmons
1 shared
Bradley J. Dworak
1 shared
Jessica Araujo
1 shared
Pratima Labroo
1 shared
Yonggang Wang

investigator

1 shared
Person Information

Name

Kula N. Jha

Role

ISSUING OFFICER

ID: 59961b64-fc92-440d-ae53-0bb03cbc9c78

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